NOVOSEVEN 1MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Eptacog alfa (activated) (Recombinant cougulation factor VIIa); Eptacog alfa

Available from:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (International Name):

Eptacog alfa (activated) (Recombinant cougulation factor VIIa); Eptacog alfa

Units in package:

0.0011.1ml1Units mL

Manufactured by:

NOVO NORDISK A/S

Patient Information leaflet

Not Applicable

Summary of Product characteristics

NovoSeven
®
30°C_Professional leaflet_pre-filled syringe_EN-Aug-2022 8-9049-00-
Based on EU text: 20220420_EN_06892_N7_ver_22
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1.
NAME OF THE MEDICINAL PRODUCT
NOVOSEVEN
®
1 MG (50 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
2 MG (100 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Eptacog alfa (activated) 1 mg/vial (corresponds to 50 KIU/vial), 1
mg/ml after reconstitution
Eptacog alfa (activated) 2 mg/vial (corresponds to 100 KIU/vial), 1
mg/ml after reconstitution
1 KIU equals 1,000
IU (International Units).
Eptacog alfa (activated) is recombinant coagulation factor VIIa
(rFVIIa) with a molecular mass of
approximately 50,000 Daltons produced in baby hamster kidney cells
(BHK
Cells) by recombinant
DNA technology.
After reconstitution, the product contains 1 mg/ml eptacog alfa
(activated) when reconstituted with
solvent.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White lyophilised powder. Solvent: clear colourless solution. The
reconstituted solution has a pH of
approximately 6.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NovoSeven
®
is indicated for the treatment of bleeding episodes and for the
prevention of bleeding in
those undergoing surgery or invasive procedures in the following
patient groups:
•
in patients with congenital haemophilia with inhibitors to coagulation
factors VIII or IX > 5
Bethesda Units (BU)
•
in patients with congenital haemophilia who are expected to have a
high anamnestic response to
factor VIII or factor IX administration
•
in patients with acquired haemophilia
•
in patients with congenital FVII deficiency
•
in patients with Glanzmann’s thrombasthenia with antibodies to GP
IIb - IIIa and/or HLA, and
with past or present refractoriness to platelet transfusions.
Severe postpartum haemorrhage
NovoSeven® is indicated for the treatment of severe postpar